Atopobium vaginae (“A. vaginae”) are a species of the Atopobium genus of bacteria. This strain was first described by Rodriguez et al. (Int. J. Syst. Bacteriol. (1999) 49:1573-1576) having been identified from the vaginal flora of a health individual. A. vaginae has since been implicated in bacterial vaginosis, wherein the A. vaginae load increases relative to other species of the natural flora. (Ferris, M., et al., BMC Infect. Dis. (2004) 4:5. Verhelst, R., et al., BMC Microbiol. (2004) 4:16). Bacterial vaginosis (BV) is a poorly detected public health problem that is associated with increased susceptibility to sexually transmitted disease, preterm delivery, pelvic inflammatory disease, neoplasia and low birth weight and for which no reliable diagnostic tool exists.
Bacterial vaginosis is currently considered to be a synergistic polymicrobial syndrome that is characterized by depletion of Lactobacillus spp., especially those that produce hydrogen peroxide, and an intense increase (100- to 1000-fold above normal levels) in the quantity of commensal vaginal anaerobic bacteria, including G. vaginalis, Prevotella sp, anaerobic gram positive cocci, Mobiluncus sp, Mycoplasma hominis, Eggerthella hongkongensis, Megasphaera sp, Leptotrichia sanguinegens and Atopobium vaginalis. (See, e.g., Swidsinksi, et al., Obstet. Gynecol. (2005) 106:1013; see also, Thies et al., J. Medical Microbiol., (2007) 56, 755.) Diagnosing of bacterial vaginosis, therefore, requires identifying each microbe present in the vaginal flora and determining their relative abundances within the floral population.
A current technique for diagnosing BV includes gram-staining assays; however, gram-staining techniques are less than optimal. One particular problem is that A. vaginae present a variable morphology that hinders identification using gram-staining. (Menard et al. Clin Infect Dis. (2008) 47(1):33-43). Nucleic acid diagnostic tests marketed for identifying BV pathogens lack components for identifying A. vaginae. (BD Affirm VPIII, Becton Dickinson, Sparks, Md.). Other nucleic acid tests rely upon universal primers and probes that detect a plurality of microbes identified in normal and disease state flora. Universal flora detection tests are known to provide confounding and incomplete results due to competition by abundant flora masking the presence of less abundant flora. Thus, results from these diagnostic assays are not fully indicative of what is occurring in a BV infection, particularly by failing to indicate the presence or abundance of A. vaginae in a specimen. There is a need for compositions, kits and methods that allow rapid and accurate diagnosis of BV, wherein said compositions, kits and methods detect the presence or abundance of A. vaginae in a specimen so that individuals may be promptly and properly treated to prevent complications from the disorder. There is also a need wherein said compositions, kits and methods detect the presence or relative abundance of A. vaginae in a specimen so that individuals may be promptly and properly treated to prevent complications from the disorder. There is also a need wherein said compositions, kits and methods detect the presence or relative abundance of each of a plurality of microbes in a specimen so that individuals may be promptly and properly treated to prevent complications from the disorder.